Drug intelligence / Profile preview

DARE-HRT1

Development stage
Phase 1
Lead developer
Daré Bioscience
Modality
Implantable Devices → Device-based Delivery → Drug Delivery Systems, Small Molecules
Administration
Intravaginal
01

Overview

DARE-HRT1 is an investigational intravaginal ring (IVR) designed to deliver a fixed-dose combination of bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period. The product is intended as a hormone therapy for the treatment of moderate-to-severe vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause in women with intact uteri. The IVR technology was developed by Dr. Robert Langer (Massachusetts Institute of Technology) and Dr. William Crowley (Massachusetts General Hospital/Harvard Medical School). Unlike other vaginal rings, this device uses a solid ethylene vinyl acetate polymer matrix to provide sustained release without the need for membranes or reservoirs[3][8]. Two dose strengths have been studied: one releasing estradiol 80 μg/day plus progesterone 4 mg/day, and another releasing estradiol 160 μg/day plus progesterone 8 mg/day[2][3][6]. Clinical studies have shown that DARE-HRT1 achieves steady-state plasma concentrations of both hormones at levels consistent with effective hormone therapy for menopausal symptoms[4][8]. Progesterone is included to counteract estrogen-induced endometrial hyperplasia in women with an intact uterus[4].

Brand names
DARE-HRT1DARE-HRT-1DARE-HRT 1
Other names
estradiol/progesterone intravaginal ringestradiol + progesterone IVR
02

Targets

PR-A (Progesterone Receptor A)ESR2 (ERβ)RB1 (Retinoblastoma-associated Protein)ESR1 (ERα)

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